Details for Patent: 9,168,239

Title:	Levothyroxine formulations
Abstract:	A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a lyophilized solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 2 to 4 milligrams mannitol.
Inventor(s):	Jiang; John Zhiqiang (Skokie, IL), Usayapant; Arunya (Mundelein, IL), Monen; George (Woodridge, IL)
Assignee:	Fresenius Kabi USA, LLC (Lake Zurich, IL)
Filing Date:	Mar 13, 2015
Application Number:	14/658,058
Claims:	1. A lyophilized solid composition, comprising: between 100 and 500 micrograms of a salt of levothyroxine; a buffer; and between 2 and 4 milligrams of mannitol. 2. The lyophilized solid composition of claim 1, wherein, when the lyophilized solid composition is stored at 25.degree. C. for a predetermined time period, less than 0.20% of the salt of levothyroxine is converted to liothyronine. 3. The lyophilized solid composition of claim 2, wherein the predetermined time period is 12 months. 4. The lyophilized solid composition of claim 1, wherein, when the lyophilized solid composition is stored at 40.degree. C. for a predetermined time period, less than 0.20% of the salt of levothyroxine is converted to liothyronine. 5. The lyophilized solid composition of claim 4, wherein the predetermined time period is 6 months. 6. The lyophilized solid composition of claim 1, wherein about 3 milligrams of mannitol is in the lyophilized solid composition. 7. The lyophilized solid composition of claim 1, wherein the buffer is a phosphate buffer. 8. The lyophilized solid composition of claim 7, wherein the phosphate buffer is dibasic sodium phosphate in an amount between 400 and 600 micrograms. 9. The lyophilized solid composition of claim 1, wherein the salt of levothyroxine is levothyroxine sodium. 10. A pharmaceutical solution, comprising: the lyophilized solid composition of claim 1; and a pharmaceutically acceptable liquid carrier. 11. The pharmaceutical solution of claim 10, wherein a concentration of the salt of levothyroxine in the pharmaceutical solution is between 5 and 500 .mu.g/mL. 12. The pharmaceutical solution of claim 10, wherein the pH of the pharmaceutical solution is between 9.5 and 11.5. 13. A method of providing levothyroxine to a patient in need thereof, the method comprising: administering the pharmaceutical solution of claim 10 to the patient in need thereof. 14. The method of claim 13, wherein the pharmaceutical solution is administered to the patient in need thereof such that between about 50 to 500 micrograms of salt of levothyroxine is administered to the patient in need thereof. 15. The method of claim 14, wherein the pharmaceutical solution is administered to the patient in need thereof such that between about 50 to 100 micrograms or about 300 to 500 micrograms of salt of levothyroxine is administered to the patient in need thereof.